Alinity m STI Assay— 510(k) K202977
Substantially EquivalentAbbott Molecular, Inc.
FDA 510(k) clearance K202977 for Alinity m STI Assay, Substantially Equivalent on 2022-04-29. Applicant: Abbott Molecular, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Molecular, Inc.
- Product code
- Code QEP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3393
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Des Plaines, IL, US
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